Purpose: ThermiSmooth® device is FDA approved for reducing facial wrinkles. It was hypothesized that the energy produced might also have a positive effect on MGD and dry eye through localized heating or neural stimulation.
Methods: 31subjects were screened using the following measures: (OSDI > 28; LLT < 85nm; TFBUT < 7 sec; Meibomian Gland Dropout grade 2 or 3; Skin Laxity or wrinkle assessment of grade >2. 18 qualified and completed the study. Prior to treatment, questionnaires, meibography and facial images were obtained by the study coordinator. A masked investigator evaluated both eyes then then left the room and the unmasked investigator treated the randomized eye. Three treatments of the test eye were done (Days 1, 15 and 30) and lasted approximately 12 minutes (42-450 C) in regions around the eye but not on the lids. The following measures were obtained: OSDI, SPEED, subjective and objective wrinkle assessment, lid laxity, tear meniscus height, NIKBUT, LLT, meibography, TFBUT with D.E.T, NaFl and Lissamine Green staining.
Results: Average age was 56 and 89% were females. Significant improvements in wrinkle self-assessment reduction (p < 0.001), OSDI (p < 0.001) and SPEED (p < 0.001) were seen. Average change in OSDI was 49 to 32.8. Average change in SPEED was 16.7 to 10.7. Some dry eye signs also showed modest improvements: 50% had an improvement in Lipid Layer Thickness (p=0.03 OU). Non-significant improvements were seen in D.E.T. TFBUT and NaFl staining. No changes were noted for lissome green straining, tear meniscus height, meibography or meibum secretion.
Conclusion(s): This pilot study demonstrated improvements in dry eye symptoms and wrinkle reduction using the ThermiSmooth® device. This effect lasted for weeks after treatment. Further studies are needed to verify treatment effects. The mechanism of action is not well established and may be linked to neuro-stimulation of the nerves supporting the meibomian glands.